MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160177

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Impaction pad broke during impaction.The event took place during a pka procedure.

Manufacturer Narrative

Corrected information: additional mfg narrative.An event regarding crack/ fracture involving a mako impactor was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed because no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been 01 other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the device was not returned for evaluation and insufficient information was provided.If the device and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Impaction pad broke during impaction.The event took place during a pka procedure.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7029015
• MDR Text Key: 93092958
• Report Number: 3005985723-2017-00562
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160177
• Device Lot Number: 19050616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR